Long COVIDCARE BEAR-LCNCT05530317
CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19
A study testing Cardiac Rehabilitation in people with Long COVID and COVID-19, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, COVID-19
- What is being tested?
- Cardiac Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required.
- Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms.
- Reduced exercise capacity <100% predicted or self-reported reduction in exercise capacity compared to pre-COVID.
- Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only).
- Agree to participate in the LIINC Study including the cardiovascular substudy if they are not already participating.
Who cannot join
- Pregnant or intention to become pregnant during study
- Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
- Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction <40% within 90 days prior to enrollment (Class I indications for cardiac rehabilitation)
- Acute myocarditis diagnosed <90 days prior
- Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
- Use of beta-blockers, non-dihydropyridine calcium channel blockers or ivabradine
Show all 11Show fewer
- Implanted pacemaker or defibrillator
- Chronic lung disease requiring the use of home oxygen therapy
- Inability to ride a sitting bicycle for CPET
- Severe post-exertional malaise or symptom worsening that would preclude participation in cardiac rehabilitation
- Medical or psychological comorbidities that would prevent safe participation in the trial, in the opinion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection ("Long COVID"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET). In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promotor score).
Read the detailed description
Study Overview
This single-center, proof-of-concept mechanistic study of cardiac rehabilitation will use a pre-post design to establish whether there is any effect of cardiac rehabilitation on adjusted heart rate reserve achieved and peak oxygen consumption (peak VO2) in LC.
Once a participant is identified as potentially eligible, they will be contacted by the study team. Participants will be asked to co-enroll in the Long-term Impact of Infection with Novel Coronavirus observational cohort ("LIINC" NCT 04362150). If participants do not agree to be co-enrolled in LIINC (if they are not already included) and the Cardiovascular Sub-Study, they will not be allowed to enroll.
Participants will be consented by the PI or research team before any procedures take place. Participants who provide written informed consent and meet the inclusion criteria will be enrolled into the study. They undergo a series of baseline measurements as outlined in the Schedule of Events. They will participate in 12 weeks of cardiac rehabilitation and then undergo follow-up measurements to determine the safety, clinical impact, and biological impact of the therapy as outlined in the Schedule of Events.
Blood collection will occur at baseline and after completion of cardiac rehabilitation as per the Schedule of Events and will be timed to stay within Red Cross Guidelines (less than 480 mL every 8 weeks).
The details of the visit schedule are outlined below. Ultimately, the most up to date Schedule of Events will be the final guide for what events are to occur at each specific study visit.
Informed Consent
The study PI or their designee will explain the risks and benefits of the study and obtain written informed consent. Those who consent to participate in the study will undergo a Screening Assessment.
Screening Assessment
Assessments performed exclusively to determine eligibility for this study will be performed only after obtaining informed consent. Assessments performed for clinical indication (not exclusively to determine study eligibility) or other research studies may be used for screening even if the studies were performed before informed consent was obtained. For example, a screening cardiopulmonary exercise test may be used to establish eligibility that was performed through clinical practice or for research through the LIINC study or RECOVER. However, these measurements may be repeated at the discretion of the PI.
Following informed consent, study screening will occur during a period of one or more visits. The Screening Assessment will include a physical examination by a study clinician (physician, nurse, or physician assistant). Details of the participant's COVID-19 history will be reviewed and/or confirmed, and a symptom assessment will be performed.
Baseline Assessments
After consenting but prior to starting cardiac rehabilitation, all participants will undergo baseline assessments including symptom assessments, cardiopulmonary exercise testing and vascular function studies.
Intervention
Participants who screen into the study and complete baseline measurements will then start standard of care cardiac rehabilitation at University of California, San Francisco (UCSF) Parnassus Campus. Exercise prescriptions will be based on the heart rate performance during the baseline CPET. Standard clinical assessments will be made to tailor recommendations during the course of cardiac rehabilitation. The intensity of the exercise prescription and level of monitoring will be tailored to the individual participant's performance on their baseline CPET according to guidelines. Exercise will be prescribed by a Cardiac Exercise Physiologist in accordance with standard cardiac rehabilitation protocols. Resistance exercise activities will also be incorporated. Recumbent exercise will be utilized based on assessment by exercise physiologist and patient. Dietary counseling, smoking cessation counseling for smokers, and medication counseling will be incorporated according to standard cardiac rehabilitation protocols. Participants are asked to commit to attending at least 24 sessions, of which 12 (one per week for 12 weeks) must be in person at UCSF Parnassus. Participants will be allowed to select a fully in-person approach (36 sessions) or hybrid approach (12-24 in person, 12-24 virtual for up to 36 total sessions).
Duration of intervention: 12 weeks
Follow Up Assessments (Week 12) After completion of cardiac rehabilitation (approximately 12 weeks after start), participants will complete the follow up assessments within 2 weeks, which will include the same assessments as baseline as well as an assessment of satisfaction with cardiac rehabilitation as measured with the net-promotor score.
- Conditions
- Long COVID, COVID-19
- Being tested
- Cardiac Rehabilitation
- Keywords
- chronotropic incompetence, cardiac rehabilitation, cardiopulmonary exercise testing
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac RehabilitationBehavioural
Exercise prescriptions will be based on the heart rate performance during the baseline CPET. The intensity of the exercise prescription and level of monitoring will be tailored to the individual participant's performance on their baseline CPET according to guidelines. Exercise will be prescribed by a Cardiac Exercise Physiologist in accordance with standard cardiac rehabilitation protocols with special attention to post-exertional malaise. Resistance exercise activities will also be incorporated. Recumbent exercise will be utilized based on assessment by exercise physiologist and patient. Dietary counseling, smoking cessation counseling for smokers, and medication counseling will be incorporated according to standard cardiac rehabilitation protocols. Most participants will participate in a hybrid approach (12-16 sessions in person), but participants will be allowed to select a fully in-person approach (36 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Participants will undergo 12 weeks of standard of care cardiac rehabilitation. Receives: Behavioral: Cardiac Rehabilitation |
| Control Arm | No intervention | No intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adjusted heart rate reserve
Adjusted heart rate reserve (peak HR-rest HR)/(220-age-rest HR) achieved during symptom-limited maximal cardiopulmonary testing performed with cycle ergometer
Measured: Baseline and 12 weeks
Change in Peak VO2 (ml/kg/min)
Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing
Measured: Baseline and 12 weeks
Secondary outcomes (11)
Change in Peak VO2 (percent predicted)
Peak VO2 (percent predicted using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing
Measured: Baseline and 12 weeks
Number of Cardiac Rehabilitation sessions attended
Number of in person and virtual sessions attended by each participant
Measured: 12 weeks
Change in Proportion with peak VO2 less than 85% predicted
Proportion with peak VO2<85% predicted (using the Wasserman equations) measured with maximal symptom limited cardiopulmonary exercise testing
Measured: Baseline and 12 weeks
Change in Number of Long COVID symptoms
Long COVID symptoms assessed using the LIINC symptom questionnaire (number of symptoms, more symptoms is worse).
Measured: Baseline and 12 weeks
Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score
Compass 31 summary score (0-100, with higher score indicating more severe autonomic symptoms).
Measured: Baseline and 12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a self-administered diagnostic instrument for depression. The PHQ-9 score ranges from 0 to 21, with higher scores indicating more severe depression.
Measured: Baseline and 12 weeks
Change in Generalized Anxiety Disorder Screener (GAD-7) Score
The GAD-7 is a self-administered diagnostic instrument for depression. The GAD-7 score ranges from 0 to 27, with higher scores indicating more severe anxiety.
Measured: Baseline and 12 weeks
Change in Short Form Survey (SF-36) Score
Overall quality of life using the short form health survey (SF-36). Scores range from 0-100 with higher scores representing a more favorable health state. The 36 questions are combined to form 8 scales in the domains of physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
Measured: Baseline and 12 weeks
Change in Quality of life assessed with EuroQol (EQ-5D) Visual Analogue Scale
Quality of life on EQ-5D VAS (0-100, with 100 being the best).
Measured: Baseline and 12 weeks
Change in Inflammation
hsCRP (mg/L) is a marker of inflammation
Measured: Baseline and 12 weeks
Net Promotor Score
Would you recommend cardiac rehabilitation to your family/friends (1-10 scale). The percentage who report 0-6 ("detractors") is subtracted from the percentage who report 9 or 10 ("promotors") to calculate a "Net Promoter Score."
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start21 Dec 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Why it stopped: PI changed institutions, exploring restarting at new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pre- post-
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew S Durstenfeld, MD MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530317
- Sponsor's protocol ID
- 22-37106
- Acronym
- CARE BEAR-LC
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdiac REhabilitation for Building Exertional heArt Rate for Chronotropic Incompetence in Long COVID-19 (CARE BEAR-LC): A Proof-of-Concept, Mechanistic Trial
- ClinicalTrials.gov ID
- NCT05530317
- Acronym / sponsor ID
- CARE BEAR-LC / 22-37106
- Conditions
- Long COVID, COVID-19
- Keywords
- chronotropic incompetence, cardiac rehabilitation, cardiopulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed institutions, exploring restarting at new institution
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proof-of-concept clinical trial is to determine whether cardiac rehabilitation improves exercise capacity and chronotropic (heart rate) response to exercise among people with Long COVID. The study will include individuals with confirmed SARS-CoV-2 infection, symptoms not present prior to COVID-19 that are persistent for at least 3 months after acute infection ("Long COVID"), and who have reduced exercise capacity less than predicted and reduced heart rate response during cardiopulmonary exercise testing (CPET). In addition to the primary outcome of change in peak VO2, secondary outcomes will include change in symptoms including autonomic symptoms (COMPASS-31), anxiety (GAD-7), depression (PHQ-9), endothelial function with brachial artery flow-mediated dilation, and satisfaction (net-promotor score).
Detailed description
Study Overview
This single-center, proof-of-concept mechanistic study of cardiac rehabilitation will use a pre-post design to establish whether there is any effect of cardiac rehabilitation on adjusted heart rate reserve achieved and peak oxygen consumption (peak VO2) in LC.
Once a participant is identified as potentially eligible, they will be contacted by the study team. Participants will be asked to co-enroll in the Long-term Impact of Infection with Novel Coronavirus observational cohort ("LIINC" NCT 04362150). If participants do not agree to be co-enrolled in LIINC (if they are not already included) and the Cardiovascular Sub-Study, they will not be allowed to enroll.
Participants will be consented by the PI or research team before any procedures take place. Participants who provide written informed consent and meet the inclusion criteria will be enrolled into the study. They undergo a series of baseline measurements as outlined in the Schedule of Events. They will participate in 12 weeks of cardiac rehabilitation and then undergo follow-up measurements to determine the safety, clinical impact, and biological impact of the therapy as outlined in the Schedule of Events.
Blood collection will occur at baseline and after completion of cardiac rehabilitation as per the Schedule of Events and will be timed to stay within Red Cross Guidelines (less than 480 mL every 8 weeks).
The details of the visit schedule are outlined below. Ultimately, the most up to date Schedule of Events will be the final guide for what events are to occur at each specific study visit.
Informed Consent
The study PI or their designee will explain the risks and benefits of the study and obtain written informed consent. Those who consent to participate in the study will undergo a Screening Assessment.
Screening Assessment
Assessments performed exclusively to determine eligibility for this study will be performed only after obtaining informed consent. Assessments performed for clinical indication (not exclusively to determine study eligibility) or other research studies may be used for screening even if the studies were performed before informed consent was obtained. For example, a screening cardiopulmonary exercise test may be used to establish eligibility that was performed through clinical practice or for research through the LIINC study or RECOVER. However, these measurements may be repeated at the discretion of the PI.
Following informed consent, study screening will occur during a period of one or more visits. The Screening Assessment will include a physical examination by a study clinician (physician, nurse, or physician assistant). Details of the participant's COVID-19 history will be reviewed and/or confirmed, and a symptom assessment will be performed.
Baseline Assessments
After consenting but prior to starting cardiac rehabilitation, all participants will undergo baseline assessments including symptom assessments, cardiopulmonary exercise testing and vascular function studies.
Intervention
Participants who screen into the study and complete baseline measurements will then start standard of care cardiac rehabilitation at University of California, San Francisco (UCSF) Parnassus Campus. Exercise prescriptions will be based on the heart rate performance during the baseline CPET. Standard clinical assessments will be made to tailor recommendations during the course of cardiac rehabilitation. The intensity of the exercise prescription and level of monitoring will be tailored to the individual participant's performance on their baseline CPET according to guidelines. Exercise will be prescribed by a Cardiac Exercise Physiologist in accordance with standard cardiac rehabilitation protocols. Resistance exercise activities will also be incorporated. Recumbent exercise will be utilized based on assessment by exercise physiologist and patient. Dietary counseling, smoking cessation counseling for smokers, and medication counseling will be incorporated according to standard cardiac rehabilitation protocols. Participants are asked to commit to attending at least 24 sessions, of which 12 (one per week for 12 weeks) must be in person at UCSF Parnassus. Participants will be allowed to select a fully in-person approach (36 sessions) or hybrid approach (12-24 in person, 12-24 virtual for up to 36 total sessions).
Duration of intervention: 12 weeks
Follow Up Assessments (Week 12) After completion of cardiac rehabilitation (approximately 12 weeks after start), participants will complete the follow up assessments within 2 weeks, which will include the same assessments as baseline as well as an assessment of satisfaction with cardiac rehabilitation as measured with the net-promotor score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pre- post-
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation | Experimental | Behavioral: Cardiac RehabilitationParticipants will undergo 12 weeks of standard of care cardiac rehabilitation. |
| Control Arm | No intervention | –No intervention control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Previously documented SARS-CoV-2 RNA positivity from an oral or nasal swab, as measured by a nucleic acid amplification test, documented positive antigen testing, or positive nucleocapsid antibody. Documentation of the positive test is required.
- Presence of persistent symptoms, defined as at least one COVID-attributed symptom newly present during acute illness or worse than baseline and reported to still be present for at least 90 days following symptom onset. This will be ascertained using study case report forms.
- Reduced exercise capacity <100% predicted or self-reported reduction in exercise capacity compared to pre-COVID.
- Willing and able to actively participate in cardiac rehabilitation including attending at least 12 in person sessions at UCSF Parnassus (intervention arm only).
Key exclusion criteria (11 listed)
- Pregnant or intention to become pregnant during study
- Pre-existing congenital heart disease, heart failure, pulmonary hypertension, heart or lung transplant, or cardiac valve surgery
- Myocardial infarction, or coronary artery bypass graft surgery, or new diagnosis of heart failure with a reduced ejection fraction <40% within 90 days prior to enrollment (Class I indications for cardiac rehabilitation)
- Acute myocarditis diagnosed <90 days prior
- Atrial fibrillation, atrial flutter, or other arrhythmias requiring antiarrhythmic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac RehabilitationExercise prescriptions will be based on the heart rate performance during the baseline CPET. The intensity of the exercise prescription and level of monitoring will be tailored to the individual participant's performance on their baseline CPET according to guidelines. Exercise will be prescribed by a Cardiac Exercise Physiologist in accordance with standard cardiac rehabilitation protocols with special attention to post-exertional malaise. Resistance exercise activities will also be incorporated. Recumbent exercise will be utilized based on assessment by exercise physiologist and patient. Dietary counseling, smoking cessation counseling for smokers, and medication counseling will be incorporated according to standard cardiac rehabilitation protocols. Most participants will participate in a hybrid approach (12-16 sessions in person), but participants will be allowed to select a fully in-person approach (36 sessions). | Behavioural | Cardiac Rehabilitation |
Primary outcome
Change in adjusted heart rate reserve
Time frame: Baseline and 12 weeks
Adjusted heart rate reserve (peak HR-rest HR)/(220-age-rest HR) achieved during symptom-limited maximal cardiopulmonary testing performed with cycle ergometer
Change in Peak VO2 (ml/kg/min)
Time frame: Baseline and 12 weeks
Peak VO2 measured with maximal symptom limited cardiopulmonary exercise testing
11 secondary outcomes
Change in Peak VO2 (percent predicted)
Time frame: Baseline and 12 weeks
Number of Cardiac Rehabilitation sessions attended
Time frame: 12 weeks
Change in Proportion with peak VO2 less than 85% predicted
Time frame: Baseline and 12 weeks
Change in Number of Long COVID symptoms
Time frame: Baseline and 12 weeks
Change in Composite Autonomic Symptom Scale-31 (Compass 31) Score
Time frame: Baseline and 12 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline and 12 weeks
Change in Generalized Anxiety Disorder Screener (GAD-7) Score
Time frame: Baseline and 12 weeks
Change in Short Form Survey (SF-36) Score
Time frame: Baseline and 12 weeks
Change in Quality of life assessed with EuroQol (EQ-5D) Visual Analogue Scale
Time frame: Baseline and 12 weeks
Change in Inflammation
Time frame: Baseline and 12 weeks
Net Promotor Score
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: PI changed institutions, exploring restarting at new institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew S Durstenfeld, MD MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation in people with Long COVID and COVID-19, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI changed institutions, exploring restarting at new institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adjusted heart rate reserve (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.